Prescription drug · ANDA

nitrofurantoin macrocrystals NDC 70756-411

Nitrofurantoin 50 mg/1 · Capsule · Oral · Lifestar Pharma LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)70756-411Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70756-0411Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
70756-411-1170756041111100 CAPSULE in 1 BOTTLE (70756-411-11)Marketed from Mar 21, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
nitrofurantoin macrocrystals
Generic name (nonproprietary)
nitrofurantoin macrocrystals
Active ingredients
Nitrofurantoin — 50 mg/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217272
Marketing start
Listing expires
Other FDA classes
Nitrofurans (Chemical structure)
Identifiers
Product ID 70756-411_9add55a0-f57d-473d-9e83-ceffe099a1b1SPL ID 9add55a0-f57d-473d-9e83-ceffe099a1b1SPL set ID 6ec66cc8-938f-4839-98c7-a51c9f1d50edRxCUI 311994, 311995, 1648759UNII 927AH8112L
Pharmacologic class
Nitrofuran Antibacterial

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N470756041111 followed by a unit qualifier and the quantity

Package 70756-0411-11. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS AND USAGE Nitrofurantoin capsules (macrocrystals) are specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli , enterococci, Staphylococcus aureus , and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules (macrocrystals) and other antibacterial drugs, nitrofurantoin capsules (macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susce…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 217272

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 217272
ProductStrengthForm · routeLabelerProduct NDC
nitrofurantoin macrocrystalsNitrofurantoin 100 mg/1CapsuleOralProficient Rx LP82804-131
Nitrofurantoin MacrocrystalsNitrofurantoin 50 mg/1CapsuleOralAmerican Health Packaging60687-839
Nitrofurantoin MacrocrystalsNitrofurantoin 100 mg/1CapsuleOralAmerican Health Packaging60687-850
nitrofurantoin macrocrystalsNitrofurantoin 100 mg/1CapsuleOralNorthwind Health Company, LLC82868-015
nitrofurantoin macrocrystalsNitrofurantoin 100 mg/1CapsuleOralREMEDYREPACK INC.70518-3827
nitrofurantoin macrocrystalsNitrofurantoin 100 mg/1CapsuleOralVERITYRX, LLC83939-0016
nitrofurantoin macrocrystalsNitrofurantoin 100 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.72789-340
nitrofurantoin macrocrystalsNitrofurantoin 25 mg/1CapsuleOralLifestar Pharma LLC70756-410
nitrofurantoin macrocrystalsNitrofurantoin 100 mg/1CapsuleOralLifestar Pharma LLC70756-412
nitrofurantoin macrocrystalsNitrofurantoin 100 mg/1CapsuleOralBluePoint Laboratories68001-605
nitrofurantoin macrocrystalsNitrofurantoin 25 mg/1CapsuleOralBluePoint Laboratories68001-603
nitrofurantoin macrocrystalsNitrofurantoin 50 mg/1CapsuleOralBluePoint Laboratories68001-604
nitrofurantoin macrocrystalsNitrofurantoin 100 mg/1CapsuleOralBryant Ranch Prepack71335-2212
nitrofurantoin macrocrystalsNitrofurantoin 100 mg/1CapsuleOralRedpharm Drug67296-2251
nitrofurantoinnitrofurantoin macrocrystalsNitrofurantoin 100 mg/1CapsuleOralA-S Medication Solutions50090-7217
Nitrofurantoin MacrocrystalsNitrofurantoin 100 mg/1CapsuleOralDirect_Rx61919-842
nitrofurantoin macrocrystalsNitrofurantoin 50 mg/1CapsuleOralBryant Ranch Prepack71335-2254
nitrofurantoin macrocrystalsNitrofurantoin 100 mg/1CapsuleOralNorthStar RxLLC72603-184
nitrofurantoin macrocrystalsNitrofurantoin 25 mg/1CapsuleOralNorthStar RxLLC72603-182
nitrofurantoin macrocrystalsNitrofurantoin 50 mg/1CapsuleOralNorthStar RxLLC72603-183

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nitrofurantoin macrocrystals NDC 70756-411 | Med-Code